FDA Adverse Event
Injury
Summary report: N
ELLIPSE DR, DF4 CONNECTOR
MDR report key: 3220053
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04498
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- May 17, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP, NONSUSTAINED LEAD NOISE WAS OBSERVED. REVIEW OF RECORDS INDICATED INTERMITTENT UNDERSENSING ON THE DISCRIMINATION CHANNEL. THE NON SUSTAINED LEAD NOISE WAS ONLY SEEN DURING TODAYS INTERROGATION. DEVICE WAS REPROGRAMMED AND WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321314 | ELLIPSE DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |